Overview
ISO 22217:2020 - Traditional Chinese medicine - Storage requirements for raw materials and decoction pieces specifies general storage principles to preserve the quality, safety and efficacy of Chinese materia medica (CMM) and processed decoction pieces. The standard defines storage area conditions, packaging and container characteristics, temperature and relative humidity categories, and special protection measures (e.g., protection from light, airtight containers). It is intended for any organisation handling raw TCM materials throughout the supply chain.
Key technical topics and requirements
- Storage area hygiene and pest control: Areas must be clean, free of rats, pests, flies and birds to prevent contamination and cross‑contamination.
- Packaging and labeling: Immediate packaging must be innocuous and non‑reactive; external packages should include product name, scientific name, origin, production/expiry dates and storage instructions.
- Temperature and humidity categories:
- Cool place: ambient temperature not exceeding 20 °C.
- Normal temperature place: 20 °C to 30 °C.
- Dry place: relative humidity (RH) ≤ 60 %.
- Moist place: RH 60 % to 100 %.
- Example requirement: items assigned to “normal temperature and dry place” are stored at 20–30 °C with RH ≤ 60 %.
- Container performance:
- Well‑closed container: protects against extraneous solids and loss under ordinary storage.
- Tightened container: prevents solids/liquids ingress and protects against efflorescence, deliquescence or evaporation.
- Protection from light: required when light affects specified properties.
- Specified storage measures: non‑powdered form, uncomminuted material, nitrogen‑filled or other specified treatments where applicable.
- Guidance annexes: national/regional reference values for temperature and RH, practical storage attention, collaborative storage methods, and lists of high‑risk or closely monitored materials.
Practical applications - who uses ISO 22217:2020
- TCM manufacturers and processors - to design warehouses and storage protocols that minimize quality loss.
- Herbal raw material suppliers and distributors - to meet storage and labeling expectations.
- Pharmacies and TCM clinics - for on‑site storage of decoction pieces and clinical raw materials.
- Quality assurance and regulatory bodies - to audit storage compliance and reduce safety/efficacy variability.
- Logistics providers - to manage temperature/humidity control during transport and storage.
Related standards
Keywords: ISO 22217:2020, Traditional Chinese medicine storage, TCM raw materials, decoction pieces, temperature and humidity, packaging, quality control.
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